CN115177857A

CN115177857A - Connector for aseptically transferring fluids

Info

Publication number: CN115177857A
Application number: CN202210973070.XA
Authority: CN
Inventors: D·E·布思; G·勒迪莫特; P·奎因; M·V·奎因
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2017-10-16
Filing date: 2018-10-15
Publication date: 2022-10-14
Also published as: EP3697475A1; US11554211B2; AU2018350894A1; MX2020003733A; AU2018350894B2; AU2021261871B2; CN111372631B; JP2022107740A; CA3079353A1; EP4169553A1; WO2019079169A1; CN111372631A; BR112020007259A2; JP2020536697A; US20190111204A1; CA3209193A1; CA3079353C; JP2024009056A; US20230133017A1; AU2021261871A1

Abstract

A drug delivery system for injecting a medicament may comprise: a housing defining a cavity; a container received within the cavity and configured to receive a medicament, the container comprising a closure; a valve assembly received within the cavity and including a piercing member configured to pierce a closure of the container; and a connector arrangement disposed between the container and the valve assembly, the connector arrangement being movable between a first pre-use position, which maintains sterility between the closure of the container and the valve assembly, and a second pre-use position, which allows fluid communication between the container and the valve assembly.

Description

Connector for aseptically transferring fluids

Description of the cases

The patent application of the invention is a divisional patent application. The original application of the divisional patent application is an invention patent application with the international application date of 2018, 10 and 15, the international application number of PCT/US2018/055849, the Chinese national application number of 201880075656.6 and the invention name of 'a connector for aseptically transferring a fluid'.

Cross reference to related applications

The present application claims priority from U.S. provisional application serial No. 62/572,730, entitled "Connector for analytical Transfer of Fluid," filed on 16/10/2017, the entire disclosure of which is incorporated herein by reference.

Technical Field

The present invention relates generally to a drug delivery device, and more particularly to a connector device for aseptically transferring fluids within a drug delivery device.

Background

Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic agents to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir that is pre-filled with a liquid therapeutic agent, and some type of automatic needle injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is typically below a certain volume, e.g. 1 ml, an autoinjector is typically used, which typically has an injection time of about 10 to 15 seconds. When the volume of fluid or drug to be administered exceeds 1 ml, the injection time typically becomes longer, resulting in difficulty for the patient to maintain contact between the device and the target area of the patient's skin. Furthermore, as the volume of drug to be administered becomes larger, it becomes desirable to increase the injection time. The traditional method of slowly injecting a drug into a patient is to start an Intravenous (IV) injection and slowly inject the drug into the patient. Such procedures are typically performed in a hospital or clinic.

Some devices allow self-injection in a home environment and are capable of gradually injecting liquid therapeutic formulations into the skin of a patient. In some cases, these devices are small enough (in both height and overall size) to allow the patient to "wear" them while infusing the liquid therapeutic formulation into the patient. These devices typically include a pump or other type of expelling mechanism to force the liquid therapeutic agent out of the reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism for initiating the flow of the liquid therapeutic agent at the appropriate time and a trigger mechanism for initiating the injection.

Disclosure of Invention

In one aspect, a drug delivery system for injecting a medicament includes: a housing defining a cavity; a container received within the cavity and configured to receive a medicament, the container comprising a closure; a valve assembly received within the cavity and including a piercing member configured to pierce a closure of the container; and a connector arrangement disposed between the container and the valve assembly, the connector arrangement being movable between a first pre-use position, which maintains sterility between the closure of the container and the valve assembly, and a second pre-use position, which allows fluid communication between the container and the valve assembly.

In another aspect, the connector device may include at least one membrane held between the container and the valve assembly. The connector means may comprise two membranes held between the container and the valve assembly. The at least one film may comprise flash spun high density polyethylene fibers. At least a portion of the connector device may extend through the housing and outside the housing. The connector means may be pulled out of the housing to move the connector means from the first position to the second position.

In another aspect, a fluid transfer system for aseptically transferring fluid between a cannula device and a container using a connector device includes a cannula device, a container, at least one membrane held between the cannula device and the container, and at least one clip configured to clip the at least one membrane between the cannula device and the container.

In another aspect, the at least one membrane may comprise two membranes. The at least one clip may comprise two clips. The sleeve device may comprise a flange extending around a portion thereof. The container may include a flange extending around a portion thereof. The at least one clip may be configured to engage a flange on the cannula device and the container to sandwich the at least one membrane between the cannula device and the container. The cannula device may include a housing and a cannula slidably positioned within the housing. The at least one membrane may comprise one of: foil, rubber or polymer. The at least one membrane may be pulled out of the housing to establish fluid communication between the cannula device and the container. The container may comprise a syringe barrel. The connector member may be arranged at the proximal end of the cannula device and the connector member may be arranged at the distal end of the container. The respective joint members may be configured to engage each other after the at least one membrane has been removed from between the cannula device and the container. At least a portion of the at least one membrane may extend through the at least one clip.

Drawings

The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

fig. 1 is a perspective view of a drug delivery system according to one aspect of the present invention.

Fig. 2 is a perspective cross-sectional view of the drug delivery system of fig. 1 in accordance with an aspect of the present invention.

Fig. 3 is a front cross-sectional view of the drug delivery system of fig. 1, according to one aspect of the present invention.

Fig. 4 is a top view of the drug delivery system of fig. 1 showing a top portion of the housing removed and the drug delivery system in a pre-use position, in accordance with an aspect of the present invention.

Fig. 5 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a pre-use position, in accordance with an aspect of the present invention.

Fig. 6 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a pre-use position, according to an aspect of the present invention.

Fig. 7 is a top view of the drug delivery system of fig. 1 showing a top portion of the housing removed and the drug delivery system in an initial actuated position in accordance with an aspect of the present invention.

Fig. 8 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in an initial actuated position, in accordance with an aspect of the present invention.

Fig. 9 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in an initial actuated position, in accordance with an aspect of the present invention.

Fig. 10 is a top view of the drug delivery system of fig. 1 showing a top portion of the housing removed and the drug delivery system in a use position, in accordance with an aspect of the present invention.

Fig. 11 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a use position, in accordance with an aspect of the present invention.

Fig. 12 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a use position, according to an aspect of the present invention.

Fig. 13 is a top view of the drug delivery system of fig. 1 showing a top portion of the housing removed and the drug delivery system in a post-use position, in accordance with an aspect of the present invention.

Fig. 14 is a top cross-sectional view of the drug delivery system of fig. 1 showing the drug delivery system in a post-use position, in accordance with an aspect of the present invention.

Fig. 15 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a post-use position, in accordance with an aspect of the present invention.

Fig. 16 is a side view of a connector for aseptically transferring fluid in the drug delivery system of fig. 1, in accordance with an aspect of the present invention.

Fig. 17A is a side view of a connector for aseptically transferring fluid in the drug delivery system of fig. 1, the connector being shown in a non-use state, according to another aspect of the present invention.

Fig. 17B is a side view of the connector of fig. 17A, shown in a use state.

Fig. 18 is a side view of a connector for aseptically transferring fluid in the drug delivery system of fig. 1, in accordance with another aspect of the present invention.

Detailed Description

The following description is presented to enable any person skilled in the art to make and use the described embodiments, which are intended to be used in the practice of this invention. However, various obvious modifications, equivalents, variations and substitutions will occur to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof shall relate to the invention as oriented in the drawing figures. It is to be understood, however, that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

Referring to fig. 1-15, a drug delivery system 10 in accordance with one aspect of the present invention includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. Drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are at least partially located within a cavity defined by housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, although other suitable arrangements for the housing 20 may be used. In one aspect, the drug delivery system 10 is an injector device configured to be worn or secured to a user and deliver a predetermined dose of medicament provided within the container 14 into the user via injection. The system 10 may be used to deliver a "bolus injection" in which the medicament is delivered over a set period of time. The medicament may be delivered over a period of up to 45 minutes, although other suitable injection amounts and durations may be used. Bolus administration (bolus administration) or delivery may or may not be rate controlled. The system 10 can deliver medicament to a user at a variable rate at a fixed pressure. The general operation of system 10 is described below with reference to fig. 1-15.

Referring again to fig. 1-15, system 10 is configured to be operated by a user engaging actuation button 26, which causes needle 28 of needle assembly 18 to pierce the skin of the user, actuation of drive assembly 12 places needle 28 in fluid communication with container 14 and expels fluid or medicament from container 14, and withdrawing needle 28 after the medicament injection is complete. The general operation of the drug delivery system is shown and described in the text of international publication nos. 2013/155153 and 2014/179774, the entire contents of which are incorporated herein by reference. The housing 20 of the system 10 includes an indicator window 30 for viewing the indicator arrangement 32 and a container window 31 for viewing the container 14, the indicator arrangement 32 being configured to provide an indication to a user regarding the status of the system 10. The indicator window 30 may be a magnifying glass for providing a clear view of the indicator arrangement 32. During use of the system 10, the indicator arrangement 32 moves with the needle actuator assembly 18 to indicate a pre-use state, a use state, and a post-use state of the system 10. The indicator arrangement 32 provides a visual indication as to the status, although other suitable indicia may be provided, such as audible or tactile indicia, instead of or in addition to indicia.

Referring to fig. 4-6, during the pre-use position of system 10, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in the retracted position. During initial actuation of the system 10, as shown in fig. 7-9, the drive assembly 12 engages the container 14 to move the container 14 toward the valve assembly 16, the valve assembly 16 being configured to pierce the closure 36 of the container 14 and place the medicament within the container 14 in fluid communication with the needle 28 via a tube (not shown) or other suitable arrangement. The drive assembly 12 is configured to engage a stopper 34 of the container 14, which stopper 34 initially moves the entire container 14 into engagement with the valve assembly 16 due to the incompressibility of the fluid or medicament within the container 14. Initial actuation of system 10 is caused by a user engaging actuation button 26, which releases needle actuator assembly 18 and drive assembly 12, as discussed in more detail below. During initial actuation, the needle 28 is still in the retracted position and is about to move to the extended position for injection to a user of the system 10.

During a use position of the system 10, as shown in fig. 10-12, with the needle 28 in an extended position, at least partially outside the housing 20, the drive assembly 12 moves the stopper 34 within the container 14 to deliver medicament from the container 14 through the needle 28 to a user. In the use position, the valve assembly 16 has pierced the closure 36 of the container 14 to place the container 14 in fluid communication with the needle 28, which also allows the drive assembly 12 to move the stopper 34 relative to the container 14 because fluid can be dispensed from the container 14. In the post-use position of system 10, as shown in fig. 13-15, needle 28 is in the retracted position and engages pad 38 to seal needle 28 and prevent any residual fluid or medicament flow from container 14. The container 14 and valve assembly 16 may be the container 14 and valve assembly 16 shown and described in international publication number WO2015/081337, the entire contents of which are incorporated herein by reference.

Referring to fig. 16-17B, in one aspect, a connector device 50 is provided between two mating components to provide a sterile connection between the two components during fluid transfer. In one aspect, the connector device 50 is disposed between a syringe barrel or container 52 and a cannula device 54. The sleeve arrangement 54 comprises a sleeve 53 which is surrounded by a housing 56 with a flange 58. The container 52 also includes a corresponding flange 60. The container 52 and the housing 56 each include a

membrane

62, 64 to provide a sterile seal of the mating portions of the container 52 and the housing 56. The

membranes

62, 64 are made of any suitable material (e.g., foil, rubber, or polymer) to maintain the sterility of the container 52, sleeve 53, and housing 56, while allowing the

membranes

62, 64 to be removed.

Referring again to FIGS. 16-17B, during assembly of the connector device 50, a clip 66 or other similar type of connector is fitted to engage the

respective flanges

58, 60 of the container 52 and housing 56 so that the

membranes

62, 64 contact one another. In one aspect, a single clip 66 is provided to clip the

flanges

58, 60 to one another. On the other hand, two clips 66 are provided to clip the

flanges

58, 60 to each other. Once the connector device 50 has been assembled, the

membranes

62, 64 may extend through one of the clips 66. Prior to use of the cannula device 54, the

membranes

62, 64 are removed from the connector device 50 to allow fluid communication between the container 52 and the cannula 53. The

membranes

62, 64 may be pulled away from the connector device 50 to allow the container 52 and housing 56 to move into engagement with one another. In one aspect, the distal end of the container 52 and the proximal end of the housing 56 may include

tabs

68, 70 to facilitate engagement between the container 52 and the housing 56. The

tabs

68, 70 may be any type of engagement and locking mechanism that connects the distal end of the container 52 and the proximal end of the housing 56.

Referring to fig. 18, a connector arrangement 50 is shown for use with the drug delivery system 10 shown in fig. 1-15. The connector device 50 is disposed between the container 14 and the valve assembly 16. In particular, the

membranes

62, 64 are held between a distal end of the container 14 and a proximal end of a valve member 72 of the valve assembly 16. In this regard, the

membranes

62, 64 form a pull tab that extends through the housing 20 of the system 10 and extends outside of the housing 20. The valve assembly 16 is configured to pierce a septum 74 held in the closure 36 of the container 14. During drug delivery of the system 10, the container 14 is pressed against the valve member 72 to expose the piercing member 76 housed in the valve member 72. The piercing member 76 pierces the septum 74 of the container 14 to establish fluid communication between the container 14 and the valve assembly 16. However, prior to use of the system 10, the

membranes

62, 64 are positioned between the container 14 and the valve assembly 16 to maintain the sterility of the components prior to use of the system 10. A portion of the

membranes

62, 64 may extend out of the housing 20 of the system 10 to allow a user to grasp the

membranes

62, 64. Prior to use of the system 10, the

membranes

62, 64 are pulled out of the housing 20 to allow the container 14 and valve assembly 16 to move toward one another during drug delivery of the system 10. In this regard, the

films

62, 64 are made of flash spun high density polyethylene fibers to allow the

films

62, 64 to be pulled without breaking or tearing the

films

62, 64. However, it is contemplated that other suitable materials may be used for the

membranes

62, 64.

Elements of one disclosed aspect may be combined with elements of one or more other disclosed aspects to form various combinations, all of which are considered to be within the scope of the invention.

While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles disclosed herein. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.

Claims

1. A drug delivery system for injecting a medicament, the system comprising:

a housing defining a cavity;

a container received within the cavity and configured to receive a medicament;

a cannula device received within the lumen, the cannula device configured to engage the container; and

a connector device disposed between the container and the cannula device, the connector device being movable between a first pre-use position maintaining sterility between the container and the cannula device and a second use position allowing fluid communication between the container and the cannula device.

2. A drug delivery system as in claim 1, wherein the connector means comprises at least one membrane held between the container and the cannula device.

3. A drug delivery system as in claim 2, wherein the connector means comprises two membranes held between the container and the cannula device.

4. The drug delivery system of claim 2, further comprising:

at least one clip configured to clip the at least one membrane between the container and the cannula device.

5. The fluid transfer system of claim 4, wherein the at least one clip comprises two clips.

6. The fluid transfer system of claim 4,

wherein the sleeve device comprises a flange extending around a portion thereof;

wherein the container comprises a flange extending around a portion thereof; and is

Wherein the at least one clip is configured to engage a flange on the cannula device and a flange on the container to clip the at least one membrane between the cannula device and the container.

7. The fluid transfer system of claim 1, wherein the cannula device comprises a housing and a cannula slidably positioned within the housing.

8. The fluid transfer system of claim 2, wherein the at least one membrane comprises one of the following options: foil, rubber or polymer.

9. The drug delivery system of claim 2, wherein the at least one membrane comprises flash spun high density polyethylene fibers.

10. The drug delivery system of claim 1, wherein at least a portion of the connector arrangement extends through the housing and to an exterior of the housing.

11. The drug delivery system of claim 1, wherein the connector means is pulled out of the housing to move the connector means from the first position to the second position.

12. The fluid transfer system of claim 2, wherein the at least one membrane is pulled out of the housing to establish fluid communication between the cannula device and the container.

13. The fluid transfer system of claim 1, wherein the container comprises a syringe barrel.

14. The fluid transfer system of claim 1, further comprising:

a connector member provided on a proximal end of the cannula device and a connector member provided on a distal end of the container, wherein the connector members are configured to engage each other after the connector device is moved from the first position to the second position.

15. The fluid transfer system of claim 2, further comprising:

a connector member disposed on a proximal end of the cannula device and a connector member disposed on a distal end of the container, wherein each connector member is configured to interengage after the at least one membrane has been removed from between the cannula device and the container.

16. The fluid transfer system of claim 4, wherein at least a portion of the at least one membrane extends through the at least one clip.

17. A fluid transfer system for aseptically transferring fluid between a container and a valve assembly using a connector device, the fluid transfer system comprising:

the container having a closure;

the valve assembly having a piercing member;

at least one membrane retained between the container and the valve assembly.

18. The fluid transfer system of claim 17, wherein the at least one membrane comprises two membranes.

19. The fluid transfer system of claim 17, wherein said at least one membrane comprises flash spun high density polyethylene fibers.

20. The fluid transfer system of claim 17, wherein the at least one membrane is removed from between the container and the valve assembly to establish fluid communication between the container and the valve assembly.

21. The fluid transfer system of claim 17, wherein the valve assembly is spaced apart from the container to maintain sterility between the closure of the container and the valve assembly when the at least one membrane is held between the container and the valve assembly.

22. The fluid transfer system of claim 17, wherein, when the at least one membrane is removed from between the container and the valve assembly, the container is moved toward the valve assembly such that the piercing member pierces the closure, and fluid first enters the piercing member when the piercing member pierces the closure of the container to allow fluid communication between the container and the valve assembly.